A Study Comparing the Efficacy and Safety of Orally Administered Ibuprofen and Placebo in Delayed Onset Muscle Soreness

NCT02113566 | Completed Phase 4 DMC

• 1 other identifier: JBR-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The hypotheses to be tested are: Efficacy: Ibuprofen will be more effective than the Placebo in relieving muscle pain/soreness over 48 hour post-dosing with study medication. Safety: There will be no or minimal increased incidence of adverse events (AEs) with Ibuprofen versus and both will be well tolerated.

Conditions

Delayed Onset Muscle Soreness

Keywords

Delayed onset muscle soreness; DOMS

Outcome Measures

Primary Outcomes (1)

• SPID (Sum Pain Intensity Difference)

  The primary efficacy parameter is muscle pain/soreness with movement at 48 hours (SPID 0-48)

  0-48 hours

Secondary Outcomes (3)

• spontaneous muscle pain/soreness

  0-48 hours

• Muscle stiffness with movement

  0-48 hours

• Overall evaluation measures

  0-48 hours

Study Arms (2)

Placebo

PLACEBO COMPARATOR

2 capsules identical to comparator, 3 times daily on Day 1 and Day 2. On Day 3 only one dose will be taken. The intervention is Acetaminophen 1000mg.

Drug: Acetaminophen 1000mg

Ibuprofen

ACTIVE COMPARATOR

2oomg capsules (400 mg per dose), 3 times daily on Day 1 and Day 2. On Day 3 only one dose will be taken. The intervention is Acetaminophen 1000mg.

Drug: Acetaminophen 1000mg

Interventions

Acetaminophen 1000mg DRUG

Subjects who require rescue medication between hours 4 and 6 will be allowed to take Dose 2 of the study medication. If the subject chooses to take a rescue analgesic (acetaminophen 1000mg), they will be considered a treatment failure. This intervention will be use for the placebo and Ibuprofen arm.

Also known as: Tylenol

Ibuprofen; Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• are male or female, 18-55 years of age
• are a sexually active female of childbearing potential willing to use a medically acceptable form of birth control throughout the study and for 30 days following the end of study participation
• have a history of experiencing muscle soreness after moderately strenuous exercise
• are in good general health, with a BMI less than or equal to 30, and able to perform the exercise regimen
• are able to read, comprehend, and sign the informed consent form
• develop muscle pain/soreness within 24-48 hours of the end of the exercise regimen and have a baseline muscle pain/soreness with movement of greater than or equal to 5 on the NRS (numerical rating scale) and at least "moderate" on the categorical scale

You may not qualify if:

• regularly works out or exercises the upper extremities with weights or gym equipment during the past 6 months
• works in an occupation that requires regular heavy lifting or involvement of the upper extremities (eg: mover, construction workers)
• allergy or intolerance to any non-steroidal anti-inflammatory drug (NSAID), aspirin or acetaminophen
• the presence of any medical condition (eg: history of bleeding ulcers or current peptic ulcer disease) that would preclude the subject from safely participating in the study'
• any form of arthritis that requires prescription or over-the-counter (OTC)treatment pregnant or lactating female
• current habituation or history of chronic use of analgesic or drugs or severe chronic pain problems that do not respond to OTC medication and/or requires a prescription analgesic
• currently on chronic NSAID therapy for any reason
• current or recent history of drug or alcohol abuse
• has taken an analgesic medication within 5 half lives of performing the exercise regimen during the run-in period or completing the baseline assessment
• has donated blood within the past 30 days
• is unable to swallow whole or large tablets or capsules
• is unable/unwilling to remain at the study center for the 6 hour inpatient observation period.
• participation in an investigational study within the past 30 days of screening
• prior participation in this trial
• site employee or close relative of a site employee directly involved in the conduct or the study or is an employee or close relative of the study doctor.

Sponsors & Collaborators

• Jean Brown Research: lead

Study Sites (1)

Jean Brown Research

Salt Lake City, Utah, 84124, United States

Location

MeSH Terms

Interventions

Acetaminophen

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Derek Muse, MD

  Jean Brown Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Derek Muse, MD

Study Record Dates

• First Submitted: April 6, 2014
• First Posted: April 14, 2014
• Study Start: February 1, 2013
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: December 2, 2015

Record last verified: 2015-12

Locations

US (1)